|Job Title:||Quality Engineer|
|Contact Name:||Rachel Radford|
|Job Published:||March 15, 2017 15:02|
Reporting to the Quality Engineering and Product Release Manager, the successful candidate will be responsible for providing guidance on all aspects of quality, and quality engineering within a cross functional team thus ensuring customer satisfaction and reduction of scrap.
- Support Operations through the product life cycle / process for defined product portfolios
- Management of process deviations, non-conformances, reworks, CAPA, Design Changes, complaints, scrap and change requests for product group
- Lead Validation activities for designated product groups
- Conduct process and GMP audits and ensure area compliance
- Liaise with regulatory department to ensure product supply is maintained and all quality aspects are met
- Champion QA and continuous improvement initiatives
- Graduate in a science, engineering or related background.
- 3-5 years in a QA Engineering / QE Experience, working within a recognised quality system within IVD, Medical Device or Pharma industry.
- 2-3 years validation experience in equipment/process/software is highly desirable.
- A working knowledge of regulatory requirements.
- A technical background or knowledge of IVD products or Medical devices would be advantageous.
- Awareness of statistical techniques and validation.
- Experience of internal, third party regulatory & external customer audits.
- In-depth knowledge of International Standards, GLP and GMP
If you are interested in this position, please don't hesitate to apply!
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